Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2034-12-31

Brief Summary

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Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis.

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Detailed Description

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Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.

Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years
2. Clinically suspected chronic liver disease based on any of:

1. Patient with historical liver biopsy providing histological evidence of any liver disease or,
2. Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
3. Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
4. Patients with metabolic risk factors predisposing to CLD

Exclusion Criteria

1. Refusal or inability (lack of capacity) to give informed consent.
2. Age \< 18 years
3. Pregnancy
4. An active malignancy.
5. Life expectation of \< 5 years.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No